UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060448 |
|---|---|
| Receipt number | R000069156 |
| Scientific Title | Biomechanical Components of Pinch in Patients with Thumb Carpometacarpal Osteoarthritis and After Thumb Opposition Reconstruction |
| Date of disclosure of the study information | 2026/01/23 |
| Last modified on | 2026/01/23 11:44:30 |
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Basic information
Public title
Biomechanical Components of Pinch in Patients with Thumb Carpometacarpal Osteoarthritis and After Thumb Opposition Reconstruction
Acronym
Biomechanical Components of Pinch in Patients with Thumb Carpometacarpal Osteoarthritis and After Thumb Opposition Reconstruction
Scientific Title
Biomechanical Components of Pinch in Patients with Thumb Carpometacarpal Osteoarthritis and After Thumb Opposition Reconstruction
Scientific Title:Acronym
Biomechanical Components of Pinch in Patients with Thumb Carpometacarpal Osteoarthritis and After Thumb Opposition Reconstruction
Region
| Japan |
Condition
Condition
Thumb Carpometacarpal Osteoarthritis and Patients with Carpal Tunnel Syndrome Following Thumb Opposition Reconstruction
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to quantitatively analyze biomechanical components (forces and torques) and muscle activity during pinching tasks in patients with thumb carpometacarpal osteoarthritis and in patients following thumb opposition reconstruction for carpal tunnel syndrome, using a pinch meter and surface electromyography, and to clarify differences in functional characteristics associated with disease and postoperative conditions.
Basic objectives2
Others
Basic objectives -Others
This is an exploratory study designed to quantitatively evaluate biomechanical components and muscle activity during pinching tasks and to characterize functional features associated with disease and postoperative conditions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean biomechanical components (forces and torques) during pinching tasks
Key secondary outcomes
Normalized integrated electromyographic activity (NIEMG) of target muscles recorded during pinching tasks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The intervention in this study consists of performing standardized pinching tasks designed for research purposes. Participants perform the pinching tasks in a seated position under predefined force conditions according to instructions. These tasks are conducted once for measurement and assessment only and are not intended as therapeutic interventions.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who meet one of the following criteria and provide written informed consent:
Individuals diagnosed with thumb carpometacarpal osteoarthritis by a physician.
Individuals who have undergone thumb opposition reconstruction for carpal tunnel syndrome and are in a stable postoperative condition.
Healthy individuals without apparent upper limb functional impairment.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
Individuals with severe pain, inflammation, or acute injury of the upper limb that interferes with performing pinching tasks.
Individuals with upper limb disorders other than thumb carpometacarpal osteoarthritis (e.g., rheumatoid arthritis, severe osteoarthritis, peripheral neuropathy).
Individuals with a history of stroke, neuromuscular disease, or central nervous system disorders.
Individuals deemed inappropriate for participation by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirokatsu |
| Middle name | |
| Last name | Iseki |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
9503198
Address
1398, shimamicho, Kita-ku, Niigatashi, Niigata
TEL
0252574497
hirokatsu-iseki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hirokatsu |
| Middle name | |
| Last name | Iseki |
Organization
Niigata University of Health and Welfare
Division name
Depertment of Occupational Therapy
Zip code
9503198
Address
1398, shimamicho, Kita-ku, Niigatashi, Niigata
TEL
0252574497
Homepage URL
hirokatsu-iseki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, shimamicho, Kita-ku, Niigatashi, Niigata
Tel
0252574455
rinri@nuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
新潟医療福祉大学（新潟県），愛野記念病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069156
